By now, audiologists are well aware that 2017 was a landmark year for audiology, or more specifically, for the industry that provides devices to manage our patients' hearing loss. Following the release of a series of reports calling for increased affordability and accessibility of hearing aids, including those from the Federal Trade Commission (FTC), the President's Council of Advisors on Science and Technology (PCAST), and the National Academies of Science, Engineering and Medicine (NASEM), President Trump signed the FDA Reauthorization Act of 2017 into law. Contained within this law is language that compels the Food and Drug Administration (FDA) to develop proposed regulations for over-the-counter hearing aids. 

Although the labeling and introduction of these devices is likely years away, the eventual disruption of the market is top of mind for anyone currently dispensing hearing devices. In reality, consumers are already being inundated with information about personal sound amplification products (PSAPs) and "hearables," which, although not regulated by the FDA or labeled for the management of hearing loss, are readily available and becoming more visible. 

The extent to which this disruption will be an innovation for hearing health care remains to be seen. In the interim, audiologists are left with questions of the unknown. Some audiologists may feel threatened by the changing environment in which emphasis is placed on the device, and the value of diagnostic and therapeutic care may seem to be minimized. Others may view looming changes as an opportunity to expand their practice to reach individuals who may not have previously considered investigating options to manage their hearing loss. Some audiologists may be worried that potential patients could do more harm by not seeking appropriate care or misusing over-the-counter (OTC) devices. Most audiologists should and do have questions about what the reality of the impact of OTC devices will be on their practices, their patients, and the reputation of the profession. 

While OTC devices have not yet entered the marketplace, the American Academy of Audiology (the Academy) recognizes that members have questions now. As the only organization of, by, and for audiologists, the Academy is committed to supporting its members in this changing health-care environment. 

Why Is a New Class of OTC Hearing Aids Being Developed?

The PCAST, FTC, and NASEM reports stemmed in part from the perception that the cost of hearing care, and more specifically the cost of hearing aids, prevents some individuals from seeking treatment for hearing loss, particularly since many third-party payers do not cover hearing aids. This includes Medicare where hearing aids and associated services are statutorily excluded. There is also concern from consumers that the cost of hearing devices is not entirely transparent, which is likely exacerbated by the perpetuation of the longstanding practice of bundling the cost of services with the device. 

Further, the geographic distribution of hearing care providers, including audiologists, is such that there are many areas in the United States in which individuals cannot readily access hearing care services. Finally, consumers are demanding greater control over their health care, including the desire to "self-direct" their hearing health care. 

These themes led to several agencies recommending consumer access to OTC hearing devices. These recommendations were based, in part, on both emerging technologies that could provide hearing benefit and the perception that an ever-increasing, technologically savvy population might have the capability to fit and program hearing devices themselves (Academy, 2018). 

What Are OTC Hearing Aids?

It is important to highlight the fact that at the time of publication of this article, OTC hearing aids do not exist. Rather, there is legislation in place that compels the FDA to create labeling that will guide the development and implementation of a new category of FDA-regulated hearing devices that are available to individuals with hearing loss without the prescription or recommendation of a licensed professional. Any discussion of the specifics of what OTC technology will involve is purely speculation at this stage. The OTC law passed by Congress (S934: FDA Reauthorization Act of 2017) defines an OTC device as one that

  1. uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation);
  2. is intended to be used by adults over the age of 18 to compensate for perceived mild-to-moderate hearing impairment
  3. through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user's hearing needs;
  4. may
    1. use wireless technology; or
    2. include tests for self-assessment of hearing loss; and
  5. is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

NOTE: Though the FDA Reauthorization Act signed into law directs the FDA to create a category of OTC hearing aids for adults with perceived mild-to-moderate hearing loss, the Academy maintains its position that OTC devices be labeled as intended for use by adults with mild hearing loss and with mild communicative impairments.

OTC hearing aids and PSAPs are not necessarily interchangeable terms. The FDA published draft guidance (DHS, 2013) that defines a PSAP as a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in certain environments, such as for hunting or other recreational activities. Although these devices are subject to applicable provisions of the Radiation Control for Health and Safety Act of 1968, under which FDA regulates electronic products that emit sonic vibrations, such as sound amplification equipment, they are not regulated for patient safety by the FDA because they are not medical devices. Audiologists could conceivably recommend OTC hearing aids and PSAPs for the mitigation of hearing loss, but it is important to recognize that PSAPs are not FDA-regulated for that indication.

Academy Recommendations to FDA

  1. Labeling for OTC devices should include language that advises the user that better outcomes are achieved when a comprehensive audiological examination is conducted prior to the acquisition of an OTC device. 
  2. Labeling should address utilization of OTC devices, including both hearing aids and/or PSAPs, by individuals younger than age 18. Specific language should be included, noting that use of OTC devices by individuals younger than age 18 should only occur under the direction of a licensed audiologist. 
  3. Labeling of OTC devices should advise consumers to seek an evaluation by an audiologist if they are not receiving satisfactory results with an OTC device. 
  4. Labeling of OTC devices should specify that the output may exceed levels that could cause either additional hearing loss or initial hearing loss in those with normal hearing. Standards for the acoustical characteristics of these devices should be set to limit these risks. 
  5. Labeling of OTC devices should advise consumers to seek an evaluation by an audiologist when they notice any change in their hearing, including temporary changes, as sustained long-term exposure to moderate-to-high output levels may have a negative effect on hearing. 
  6. The Academy recommends that the FDA regulations related to the sale and purchase of OTC devices specify that OTC devices are medical devices and not consumer electronics. 
  7. The FDA should take steps to mitigate consumer confusion regarding the difference between PSAPs and OTC hearing aid devices. 

When Will OTC Hearing Aids Be Available?

The law mandates that the FDA develop and publish rules no later than three years after the enactment of the law. The FDA has begun the process of collecting information and data, including input from professional organizations, federal agencies, and consumer groups, and could publish proposed rules anytime within the next three years. Included in the proposed rules will be the time frame for the FDA to receive feedback from the public on the proposed rules. 

During this time, organizations, agencies, or individuals can provide comments, suggest modifications, or suggest different options for the proposed rules. It is also possible that the FDA will hold a public hearing at which time oral testimony can be provided on the proposed regulations. At the close of the comment period, the FDA will evaluate any oral or written testimony and determine whether any changes in the proposed rules are necessary. Within six months (180 days) of the close of the comment period, final rules will be published, along with a date of enactment (Academy, 2018). 

How Is the Academy Representing Audiologist Interests?

The Academy has been actively engaged in responding to announcements related to OTC hearing aids and also has been proactively involved in influencing the development process by remaining in close and constant communication with key federal agencies, including the FTC and FDA, as well as key legislators. 

In October 2017, several Academy Board members had the opportunity to meet with the FDA and provide a number of recommendations (see sidebar 1) that Academy leadership believes are important to protect the best interest of consumers. 

Also in 2017, the Academy released a statement (Academy, 2017) regarding the accessibility and affordability of hearing health care for adults. In part, this statement supported consumer autonomy with respect to control over their health-care decisions, as well as the concept that consumers may be able to "self-identify" the presence of a communication problem, functional limitation, or participation restriction; however, the Academy did not support the concept of "self-diagnosis" and "self-treatment." The Academy believes individuals who have self-identified a hearing loss or communicative impairment are best served when diagnosis leads to the development of a comprehensive treatment plan that may include instruction, counseling, rehabilitative services, and/or amplification products. 

Furthermore, the Academy endorsed the need for increased awareness of hearing loss and its comorbidities as part of annual primary care examinations, and encouraged increased referral for a comprehensive evaluation with the understanding that there is no "normal" age-related hearing loss, and any degree of hearing loss should be appropriately evaluated. In short, the Academy endorsed completing a hearing test anytime hearing loss is suspected and encourages members to do the same, on any available platform. 

The Academy is also actively working to position itself to be a go-to resource for media, legislators, and industry to represent the interests of members and patients who expect the highest quality of evidence-based care. The Academy recognizes that questions regarding the changing landscape of hearing management abound and has developed a guidance document to assist audiologists in understanding the differences between existing products and OTC devices, to be ready to answer questions about these devices, and possibly to begin to pre-position clinical practices in anticipation of the availability of OTC devices. This guidance will be updated as the regulations for OTC devices become available. The guide is available on the Academy's website.

Example Resources for Non-Audiologists

  • Hearing Health Overview
  • Signs of Hearing Loss
  • Types of Hearing Loss
  • Who to See/Who Are Audiologists
  • Types of Hearing Devices
  • Financial Considerations
  • Tips for Successful Manage-ment of Adult Hearing Loss

How Can the Public Prepare for OTC Hearing Aids?

The Academy recognizes its role as a reputable resource for patients and is committed to increasing public awareness of hearing loss, hearing devices, hearing protection, and the role of the audiologist. The Academy also recognizes that OTC hearing aids are not the only aspect of management of hearing loss that may be confusing to those seeking care. There are numerous providers, facilities, and pricing structures. While hearing aids are the most recognizable intervention for hearing loss, implantable options may be more appropriate in certain cases; however, many people who are candidates for implantable technologies never know their hearing could be improved with something other than hearing aids. Patients also may not be aware of the benefits of assistive technologies and aural rehabilitation and the necessity of seeking care that is comprehensive in its approach. And of course, consumers are being inundated with media publications with headlines heralding the introduction of OTC hearing aids to the market. 

The Academy knows that consumers are seeking to self-direct their hearing care and frequently seek their own information outside of a health-care provider's office. For this reason, a series of guidance documents for consumers (see sidebar to the right) are being developed to assist individuals with hearing loss in understanding the differences among existing products and OTC devices, their hearing health-care provider's credentials, questions to ask when considering hearing devices, and why hearing health care is so important. 

These guides are also excellent resources for referring physicians, legislators, insurers, and the media to reference when considering best practices when seeking hearing health care. These guidance documents will be updated as the regulations for OTC devices become available. Resources are available on the Academy's website.

How Can Audiologists Prepare for OTC Hearing Aids?

Unfortunately, the concepts of "hearing devices" and "hearing health care" have become interchangeable in the common jargon. That is to say, many individuals assume a hearing device is the sole component of hearing health care. In fact, hearing devices are simply one aspect of a comprehensive and multifactorial approach to achieving optimal hearing. OTC hearing aids are one type of device on a spectrum of management options ranging from personal sound amplifiers to implantable hearing devices. 

Furthermore, all hearing devices are one component of a comprehensive evaluation and treatment plan that typically begins with evaluation of hearing ability and speech understanding and may include discussion of aural rehabilitation and communication strategies, tinnitus management therapies, and assistive and alerting devices. Hearing health care encompasses a range of services and technologies that together can improve an individual's overall experience. Moving forward, it is necessary for audiologists to lead the conversation regarding the importance of comprehensive evaluation and supplemental services in the overall management of hearing loss.

Strategies for Successful Practice 

1. Be highly transparent in your communication with patients.
In addition to the creation of an OTC category of hearing aids, the NASEM (2016) report also called for audiologists to empower consumers and patients in their use of hearing health care. This includes increased transparency for consumers to understand their options in obtaining hearing health care. Audiologists should be sure to utilize meaningful test batteries and review the results and implications with patients in understandable terms.

Discuss with patients the advantages of appropriate management of their hearing loss and the many ways in which their lives can be improved by seeking hearing care. Routinely apply best practices to all aspects of practice and demonstrate to patients why those practices are directly beneficial to them.

Finally, be transparent in communications regarding costs; the Academy encourages its members to distinctly describe device and professional fees to support patients' greater understanding of costs associated with their care.

2. Lead the conversation by enhancing public awareness.
There is a need to improve publicly available information on hearing health, as highlighted in the NASEM (2016) report. It is unrealistic to expect that audiologists can make a meaningful difference to public messaging by only interacting with the patients in their own practices. Take the important message of "have your hearing tested" to any platform you can. Audiologists can influence the messaging consumers are receiving and help change the conversation from device oriented to care oriented, but it will be necessary for all audiologists to commit to changing the conversation.

The Academy offers numerous resources through the website (Academy, 2018b) including consumer fact sheets and a public relations tool kit. Reach out to referring physicians, local media, and use electronic media to emphasize the importance of hearing evaluations. Not sure you know how to interact with the media? Plan to attend the Public Relations Media Training Learning Lab at AAA 2018, or one of two one-hour mini media training sessions in the exhibit hall. 

Four topic areas on which to focus your public awareness outreach efforts include the following:

  • The insidious nature of hearing loss, its impact and comorbidities, and why seeking good care early is key to successful mitigation
  • The role of audiologists and how audiologist training/scope of practice differs from other hearing care providers
  • Importance of hearing care, not only devices, in successfully managing communication challenges associated with hearing loss
  • When discussing hearing devices, emphasize the importance of obtaining a comprehensive audiological evaluation before pursuing intervention

3. Prepare your practice.
The Academy recommends a hearing care delivery model that optimizes safe and effective management of hearing loss and is firm in its position that such a model includes the following: 

The Academy also recognizes that the spectrum of hearing management options may appropriately include OTC devices when they become available, provided that a comprehensive hearing test has been completed and the technology is appropriate for the hearing loss. As such, audiologists may consider how to incorporate these devices into their practices and should begin considering how they may address questions from consumers regarding selection and maintenance. Reconsideration of an "unbundled" pricing structure may be most advantageous, particularly when offering these devices (Academy 2016 and 2016b).

It is also important for audiologists to note that although the FDA has announced that it intends to no longer enforce the requirement of the medical waiver prior to fitting a hearing aid, at time of publication, this requirement remains on the federal register. The FDA released this information through a guidance document, which only serves as a recommendation, unless specific regulatory or statutory requirements are cited. As such, most state licensing agencies would still enforce the requirement until such time as the requirement is removed at the federal level.

States may also have their own waiver requirements written into state licensure rules or statues. Certain payers may also require a letter of medical necessity or physician referral prior to the dispensing of hearing aids. Audiologists should contact their state licensing agencies with questions, but it is likely that the practice of obtaining clearance or a waiver must continue at this time. 

  1. Determination of appropriate management options based on a comprehensive evaluation and individual hearing needs assessment performed by an audiologist;
  2. Consideration of a spectrum of hearing management options that may be appropriate, including, but not limited to, hearing aids, assistive listening devices, implantable technologies, communication strategies, and auditory-based therapy;
  3. Recommendation for medical assessment and intervention when appropriate;
  4. Counseling and recommendations that are cognizant of individual factors that may limit access to appropriate hearing health care, including but not limited to geographic constraints and financial limitations (Academy, 2018).

Conclusion

As the landscape of hearing health care shifts and adjusts to the disruption that OTC hearing aids may bring to the hearing technology market, the Academy remains committed to the best interests of our members and patients. 

Fundamentally, the care audiologists provide has not changed. The value audiologists bring to the successful management of hearing loss must be recognized by the public in order to be impactful. In a highly technical society dependent on gadgets and gizmos, it is natural that consumers would focus on a device to solve their concerns. It is the role of audiologists to educate the public about the role of the device in a comprehensive management program and to encourage anyone concerned about their hearing to seek appropriate evaluation and care. 

The Academy leadership will continue to work to make resources available to members to share in their communities, but the effectiveness of these efforts rests on the commitment of the membership to utilizing those resources. The future of audiology depends on all of us. 


Acknowledgements: The following Academy Board members were part of the working group that developed the Academy Guidelines that contributed to the content of this article. Thank you to Bopanna Ballachandra, PhD; Melissa Heche, AuD; Tracy Murphy, AuD; Brad Stach, PhD; and Ian Windmill, PhD.